In the in vivo studies of Singulair® granules (4 mg) administered to infant patients, medicine administration was conducted by mixing the formulation with different vehicles: formula (5 mL) to infants 1 to 3 months, and applesauce (15 g) to infants from 3 to 24 months (two subgroups: 3 to 6 and 6 to 24 months). The prandial state of the patients in these studies was not disclosed and potential vehicle-induced differences on drug behaviour were not considered (16,17,19,23).